Analysis of Medicinal Product Utilization Data in the FDA Sentinel System to Inform the Development of a Pregnancy Safety Study Framework 

As part of the FDA User Fee Reauthorization Act of 2022, FDA committed to developing a pregnancy safety study framework to optimize the study types (single-arm descriptive, pregnancy registry, or database studies) to assess medicinal product exposure in pregnancy. The framework will leverage estimated magnitude of exposure
and study goal (signal identification or evaluation) to optimize the study types to assess safety.

This poster characterizes and describes the magnitude of exposure during pregnancies that ended in live births for medicinal products either (1) with an FDA-issued pregnancy safety postmarketing requirement or commitment, (2) listed on the FDA’s Office of Women’s Health Pregnancy Registry webpage, or (3) with a pregnancy observational study in ClinicalTrials.gov.  It was presented at the 2024 ISPE Annual Meeting.